CFR section
21 CFR 111.140(b)(3): Under this subpart F, what records must you make and keep?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart F-Production and Process Control System: Requirements for Quality Control
Key facts
| Citation | 21 CFR 111.140(b)(3) |
|---|---|
| Section | Under this subpart F, what records must you make and keep? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart F-Production and Process Control System: Requirements for Quality Control |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (3) Documentation of any material review and disposition decision and followup. Such documentation must be included in the appropriate batch production record and must include: (i) Identification of the specific deviation or the unanticipated occurrence; (ii) Description of your investigation into the cause of the deviation from the specification or the unanticipated occurrence; (iii) Evaluation of whether or not the deviation or unanticipated occurrence has resulted in or could lead to a… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.